FDA UDI
In Commercial Distribution
🇺🇸 United States
iQ200
DI: 10837461001355
·
Model: Elite Plus (US) (2008 Version) (NA)
·
BECKMAN COULTER IRELAND INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iQ200
- Primary DI
- 10837461001355
- Version / Model
- Elite Plus (US) (2008 Version) (NA)
- Catalog Number
- 700-3375
- Company Name
- BECKMAN COULTER IRELAND INC.
- Labeler DUNS
- 985071975
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-07
- Public Version
- 5
- Public Version Date
- 2023-10-13
- Public Version Status
- Update
- Public Device Record Key
- 16f1ebc6-8b08-426e-9fd7-3345e1967c7c
Device Description
"iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA); 800-7714 IRICELL 2000 Plus (NA)"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KQO | Automated Urinalysis System | Clinical Chemistry | 862.2900 | 1 |
| LKM | Counter, Urine Particle | Hematology | 864.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35918 | Urine analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10837461001355 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022774 | 000 |